Life Science People are looking for a Quality driven, customer-centric, honest and passionate individual to join a vibrant growing company that is focused on clinical trial delivery. This is a brand-new role for a Quality Manager to create Quality infrastructure, and build, develop and maintain a robust and efficient paper-based Quality System.
Reporting to the Managing Director, your role will include:
- You will take primary responsibility for managing the ongoing QA activities for the Organisation, supporting our Good Clinical Practice (GCP) and Clinical Trial obligations.
- You will perform Clinical Investigator Site Audits, GCP Document Audits, Internal Process Audits and Vendor/System Audits
- You will also lead on any regulatory authority inspection activities.
- You will work closely with Clinical Operations, Information Technology, and other supporting areas/ teams, to drive a culture of Quality within the company
Skills and Experience Required:
- Minimum degree (BSc) in Life Science or related discipline.
- 5 years + of demonstrated QA experience in regulated industry such as pharma, biotech, CRO.
- Full understanding of ICH/FDA GCP guidelines, with an extensive knowledge of GCP.
- Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice.
- Experience of developing and maintaining paper-base Quality Management Systems
- Understand device regulations, development processes and FDA / EMA/MHRA inspection procedures is also required.
- Experience with effectively managing FDA / EMA/ MHRA inspections, working with regulators and customer audits.
- Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs.
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently
- Ability to negotiate and liaise with clients/vendors in a professional manner.
If interested, please submit your CV and cover letter highlighting your expertise in relation to the role. We will send you a confirmation of acknowledgement, please note feedback can take up to 2 weeks. If you have been selected for an interview the process will be divided into the following 3 stages :
First stage - Telephone call with our HR representative.
This is a general call to find out a little bit about what you would be looking for within the organisation and to provide some general details about yourself.
Second Stage - A formal interview at Head Office with hiring managers
Depending upon the position applied for, you may be required to undertake a formal presentation.
Final stage - An observational day at the Head office, where you will join some of the team and be involved in activities related to the role you are applying for. This usually takes between 3-4 hours. All candidates will receive feedback throughout the recruitment process.
This is a full-time permanent position, paying up £60,000 plus benefits. You will be based in the company's UK site in Hertfordshire, although the company offers some flexibility to work from home. Full details will be provided on application.